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SPC, UK: Bezalip 200mg tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Actavis UK Ltd
Διεύθυνση :
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
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Δωρεάν εγγραφή

Name of the medicinal product

Bezalip. Bezafibrate 200mg Tablets.

Qualitative and quantitative composition

Bezafibrate 200mg.

Pharmaceutical form

Tablet for oral use. Bezalip is a round film-coated tablet with a white core and is imprinted G6.

Therapeutic indications

Bezalip is indicated for use in hyperlipidaemias of Type IIa, IIb, III, IV and V (Fredrickson classification). Bezalip should be employed only in patients with a fully defined and diagnosed lipid abnormality ...

Posology and method of administration

Adults The recommended dosage for Bezalip tablets is one tablet three times a day, equivalent to 600mg bezafibrate. Each tablet should be swallowed whole with sufficient fluid after a meal. Occasionally ...

Contraindications

Significant hepatic disease (other than fatty infiltration of the liver associated with raised triglyceride values). Gall-bladder diseases with or without cholelithiasis. Patients with nephrotic syndrome ...

Special warnings and precautions for use

Bezafibrate should be used as an adjunct to diet and measures such as physical activity, weight loss and adequate treatment of other metabolic disorders (e.g. diabetes, gout). Secondary causes of dyslipidaemia, ...

Interaction with other medicinal products and other forms of interaction

Care is required in administering Bezalip to patients taking coumarin-type anti-coagulants, the action of which may be potentiated. The dosage of anti-coagulant should be reduced by up to 50% and readjusted ...

Pregnancy and lactation

There are limited data from the use of bezafibrate in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Bezalip is not recommended during pregnancy and in women of ...

Effects on ability to drive and use machines

Bezalip has been shown to cause dizziness and can have a minor to moderate effect on the ability to drive or use machines. Patients should not drive or use machines if they are affected.

Undesirable effects

The overall safety profile of bezafibrate is based on a combination of clinical study data and post-marketing experience. The frequency of adverse drug reactions (ADRs) according to MedDRA System Organ ...

Overdose

No specific effects of acute overdose are known. Rhabdomyolysis has occurred. In cases of rhabdomyolysis, bezafibrate must be stopped immediately and renal function carefully monitored.

Pharmacodynamic properties

ATC Code: C10AB02 Mechanism of Action Bezafibrate lowers elevated blood lipids (triglycerides and cholesterol). Elevated VLDL and LDL are reduced by treatment with bezafibrate, whilst HDL-levels are increased. ...

Pharmacokinetic properties

Absorption Bezafibrate is rapidly and almost completely absorbed from the standard film-coated tablet formulation. A peak plasma concentration of about 8mg/L is reached after 1–2 hours following a single ...

Preclinical safety data

The chronic administration of a high dose of bezafibrate to rats was associated with hepatic tumour formation in females. This dosage was in the order of 30 to 40 times the human dosage. No such effect ...

List of excipients

Table core: Maize starch Microcrystalline cellulose Colloidal silicon dioxide Sodium starch glycollate Magnesium stearate Film-coating: Polyvinyl alcohol Titanium dioxide (E171) Macrogol Talc

Incompatibilities

Not applicable.

Shelf life

5 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Packs of 84 or 100 tablets in PVC/Aluminium blister strips.

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

Actavis Group PTC ehf Reykjavíkurvegi 76-78 220 Hafnarfjordur Iceland

Marketing authorization number(s)

PL 30306/0125

Date of first authorization / renewal of the authorization

1 April 1999

Date of revision of the text

25.11.2011